Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke

Hyperglycemia Clinical Trial

— GLIAS-III  

Official title:

Glycemic Variability: Prognostic Impact on Acute Ischemic Stroke and Impact of the Corrective Treatment for Hyperglycemia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04001049
• Other study ID #: GLIAS-III
• Status: Recruiting
• Start date: June 30, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2020
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Blanca Fuentes Gimeno
• Phone: +34917277444
• Email: blanca.fuentes[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multicenter observational clinical study in patients with acute ischemic stroke. The main objective is to evaluate the impact of glycemic variability (GV) on stroke outcome (mortality, functional recovery) of patients with acute ischemic stroke. Glycemic variability will be assessed using a subcutaneous device for continuous glycaemia motorization during 96 hours; also capillar glycaemia will be measured every 6 hours.

Description:

10 different hospitals in Spain will participate in this study, recruiting a total of 340 patients. Once the informed consent form is signed, the subcutaneous device for continuous glycaemia motorization will be implanted and demographic, comorbidities and treatments of every patient will be registered. During the first 96 hours, capillar glycaemia, NIHSS scale, HbA1C levels, cerebral recanalization treatment and glycaemia correcting treatments will also be reported. In the following days (7, 30 and 90 days after stroke) modified Rankin Scale, NIHSS scale and stroke secondary prevention treatments will be evaluated. At day 90, a new measure of HbA1C will be done.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years old

• Inclusion less than 24 hours from ischemic stroke

• Functional independence prior to stroke

• Signed informed consent

Exclusion Criteria:

• Transient cerebral ischemia

• Prevision of need to perform a magnetic resonance within the first 96 hours from inclusion

• Concomitant severe or deadly disease that may interfere with study follow-up during 3 months from stroke

• Current drug or alcohol abuse that may interfere with study follow-up

• Participation in a clinical trial

Related Conditions & MeSH terms

• Brain Ischemia
• Glycemic Variability
• Hyperglycemia
• Ischemia

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic variation impact in mortality of patients with acute ischemic stroke	Intrahospital mortality	3 months from stroke
Primary	Glycemic variation impact in functional status of patients with acute ischemic stroke	Modified Rankin Scale. This scale measures degree of disability/dependence after a stroke.; 0- No symptoms; No significant disability despite symptoms; able to perform all usual duties and activities.; Slight disability; unable to perform all previous activities but able to look after own affairs without assistance.; Moderate disability; requires some help but able to walk without assistance.; Moderate severe disability; unable to walk without assistance an unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requires constant nursing care and attention.; Death	3 months from stroke
Secondary	Impact of glycemic variation in mortality in diabetic patients with acute ischemic stroke.	Intrahospital mortality	3 months from stroke
Secondary	Impact of glycemic variation in functional status in diabetic patients with acute ischemic stroke.	Modified Rankin Scale. This scale measures degree of disability/dependence after a stroke.; 0- No symptoms; No significant disability despite symptoms; able to perform all usual duties and activities.; Slight disability; unable to perform all previous activities but able to look after own affairs without assistance.; Moderate disability; requires some help but able to walk without assistance.; Moderate severe disability; unable to walk without assistance an unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requires constant nursing care and attention.; Death	3 months from stroke